(70 days)
Giraffe2 is a paste containing a hemostatic agent which is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam.
Giraffe2 is a paste containing a hemostatic agent which is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures such as, but not limited to, dental impressions, seating of temporary and permanent restorations, restorations of cavities and placement of a rubber dam. Girgffe2 is a tissue management solution that allows clinicians to quickly and easily obtain sulcular expansion in clinical situations prior to an impression. Additionally, Giroffe2 will help stop bleeding and prevent the flow of crevicular fluid upon removal, further assuring accurate and complete impressions.
The provided text does not contain specific acceptance criteria or a detailed study proving the device meets particular criteria in the format requested. The document is a 510(k) summary for a medical device (Giraffe2), focusing on its substantial equivalence to a predicate device (Expa-syl).
Here's an analysis based on the information provided, highlighting what is present and what is missing:
1. A table of acceptance criteria and the reported device performance
- Missing. The document states that "Biocompatibility studies have been completed on Giraffe2, which demonstrate that the material is safe for its intended use" and "This 510(k) submission also includes data from bench testing used to evaluate the physical properties of Giraffe2 compared to the predicate device, Expa-syl." However, it does not provide specific acceptance criteria (e.g., "retraction depth must be X mm") or quantitative performance data. It broadly concludes that "Based upon the biocompatibility and bench testing, the clinical performance of Giraffe2 is deemed to be substantially equivalent to the predicate device."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing. The document mentions "biocompatibility studies" and "bench testing" but does not provide details on sample sizes, study designs (prospective/retrospective), or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This type of information is typically relevant for studies involving expert interpretation or consensus (e.g., imaging studies, diagnostic devices). For a gingival retraction paste, the evaluation would likely involve objective measurements or clinical observations rather than expert "ground truth" establishment in this sense. No such expert involvement is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As with point 3, this is for studies involving expert interpretation. No adjudication method is mentioned or implied.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. The device is a gingival retraction/hemostatic paste, not an AI-powered diagnostic tool. Therefore, MRMC studies or AI assistance are irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. As above, this is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Implicitly objective/benchmarking. While not explicitly stated as "ground truth," the evaluation of Giraffe2 relies on biocompatibility studies and "bench testing" of "physical properties" compared to a predicate device. This suggests that the "ground truth" or reference points are likely established through standardized biological tests (for biocompatibility) and objective physical measurements (for bench testing) against a known device.
8. The sample size for the training set
- Not applicable / Missing. There's no indication of a "training set" as this is not a machine learning or AI device. If "training set" refers to samples used for product development prior to formal testing, that information is not provided.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an AI/ML model is involved.
Summary of available information regarding compliance/testing:
- Acceptance Criteria/Performance: The device is "substantially equivalent" to Expa-syl based on biocompatibility and bench testing. The key difference highlighted is the removal method (light-cured vs. rinsed). No specific quantitative criteria or performance metrics are provided.
- Study Type: Biocompatibility studies and bench testing were performed.
- Comparison: The device's performance was compared to a predicate device, Expa-syl.
- Conclusion: The studies demonstrated the material is safe for its intended use and that the clinical performance of Giraffe2 is substantially equivalent to the predicate device.
N/A